Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)

Hepatitis B Clinical Trial

— IMPHROVE-D  

Official title:

Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04863703
• Other study ID #: 9644_BO_S_2021
• Status: Recruiting
• Start date: May 7, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Hannover Medical School
• Contact: Benjamin Maasoumy, MD
• Phone: +49511 532 6529
• Email: Maasoumy.Benjamin[@]mh-hannover.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Portal hypertension (PH) is one of the key drivers of clinical deteoration in patients with liver cirrhosis. It has been demonstrated that antiviral therapy in patients with chronic hepatitis C infection leads to a decrease of PH and is associated with an improved outcome. Recently, Bulevirtide was approved for the treatment of patients coinfected with hepatitis B (HBV) and chronic hepatitis delta (HDV) infection, which helps to achieve viral supression in these patients. This study investigates the potential effects of viral supression on PH in patients with chronic HBV/HDV infection and liver cirrhosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 11
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Chronic HBV/HDV Coinfection
• suspected or diagnosed liver cirrhosis, indication for hepatovenous pressure gradient (HVPG) measurement or liver cirrhosis and HVPG measurement conducted in the past 12 months (conducted prior to antiviral treatment)
• indication for antiviral treatment with Bulevirtide
• age >18years
• Must be willing to participate in the study and provide written informed consent

Exclusion Criteria:

• patient rejects study participation
• no conducted or no indication for HVPG measurement
• age <18years

Related Conditions & MeSH terms

• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis D
• Hypertension
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Drug:
• Bulevirtide
Patients with liver cirrhosis and HBV/HDV coinfection receive Bulevirtide as an antiviral therapy irrespective of the study, this study is observational.

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change the degree of portal hypertension after inducing viral suppression via antiviral treatment with Bulevirtide	Change of hepatovenous pressure gradient (HVPG) in mmHg underviral suppression with Bulevirtide in patients with HBV/HDV coinfection and liver cirrhosis. HVPG measurement will be assessed via transjugular HVPG measurement.	Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Secondary	Change of Quality of life under viral suppression with Bulevirtide	Change of Quality of life is assessed via SF-36 questionnaire.	Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment.
Secondary	Change in minimal hepatic encephalopathy (HE) status under viral suppression	Change in minimal HE status is evaluated via PSE-testing, critical flicker frequency and animal naming test.	Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Secondary	Change of nutritional status under viral suppression with Bulevirtide	Change of nutritional status will be evaluated via repeated measurement of BMI (in kg/m2), arm circumference and triceps skin fold thickness.	Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Secondary	Change of physical ability under viral suppression with Bulevirtide	Change of physical ability is assessed via liver-frailty Index.	Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Secondary	Change of the inflammatory profile under viral suppression with Bulevirtide	Change of the inflammatory profile will be assessed through Cytokines using Bio-Plex Pro Human Cytokine Screening Panel, 48-Plex, Bio-Rad, Olink Target 96 Inflammation and Olink Proteomics.	Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.
Secondary	Change in liver stiffness under viral suppression with Bulevirtide	Change in liver stiffness will be assessed via transient elastography.	Measurement before Bulevirtide intake (baseline) and one year after establishing antiviral treatment with Bulevirtide.
Secondary	Clinical endpoints under viral suppression with Bulevirtide	Assessed clinical endpoints are: Resolution of esophageal varices and incidence of esophageal bleeding, hepatic encephalopathy or ascites.	Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.